NCT01882543 (LEADERSHIP) is a Phase 2 clinical trial of AQX-1125 in Interstitial Cystitis, sponsored by Aquinox Pharmaceuticals (Canada) Inc..

Who is sponsoring NCT01882543?

NCT01882543 is sponsored by Aquinox Pharmaceuticals (Canada) Inc..

What drugs are being tested in NCT01882543?

Interventions in NCT01882543: AQX-1125, Placebo.

What condition does NCT01882543 study?

NCT01882543 studies Interstitial Cystitis, Bladder Pain Syndrome.

Is NCT01882543 still recruiting?

NCT01882543 is currently completed. Last updated 3 August 2017.

Are results published for NCT01882543?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-03 · How we verify

NCT01882543: LEADERSHIP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway

Completed Phase 2 Results posted Last updated 3 August 2017

What this trial tests

Phase 2 trial testing AQX-1125 in Interstitial Cystitis in 69 participants. Completed in 1 June 2015.

Timeline

1 June 2013

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Aquinox Pharmaceuticals (Canada) Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	69
Start date	1 June 2013
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	29 locations across United States, Canada

Drugs / interventions tested

AQX-1125 — full drug profile →
Placebo

Conditions studied

Interstitial Cystitis — all drugs for Interstitial Cystitis →
Bladder Pain Syndrome — all drugs for Bladder Pain Syndrome →

Sponsor

Aquinox Pharmaceuticals (Canada) Inc. — full company profile →

Who can join

Adults 18 to 75, female only, with Interstitial Cystitis or Bladder Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)
Time frame: Baseline to Week 6
Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.

Sponsor's own description

The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

PI3K inhibitors in inflammation, autoimmunity and cancer.
Stark AK, Sriskantharajah S, Hessel EM, Hessel EM, et al · · 2015 · cited 236× · PMID 26093105 · DOI 10.1016/j.coph.2015.05.017
Broaden Horizons: The Advancement of Interstitial Cystitis/Bladder Pain Syndrome.
Li J, Yi X, Ai J. · · 2022 · cited 27× · PMID 36498919 · DOI 10.3390/ijms232314594

Verify or expand the search:

Other trials of AQX-1125

Trials testing the same drug.

NCT03478020 — Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study · Phase 1 · completed

Other recruiting trials for Interstitial Cystitis

Currently open trials in the same condition.

NCT06299683 — Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment · NA · recruiting
NCT05696444 — Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO) · NA · active not recruiting
NCT05485207 — Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome · EARLY_PHASE1 · active not recruiting
NCT04734847 — Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain Syndrome · NA · recruiting
NCT00499317 — Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) · recruiting

Other Aquinox Pharmaceuticals (Canada) Inc. trials

Trials by the same sponsor.

NCT03500159 — Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome · Phase 2 · terminated
NCT03478020 — Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study · Phase 1 · completed
NCT03185195 — Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125 · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01882543 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aquinox Pharmaceuticals (Canada) Inc.
Last refreshed: 3 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01882543.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing